Principal Biostatistician (FSP)

ThermoFisher Scientific; Países Baixos; Teletrabalho; EUR 90 000 - 120 000; Tempo integral

Resumo da oferta

Thermo Fisher Scientific in the Netherlands seeks a Principal Scientist in Biostatistics to advance life-changing therapies through statistical excellence. You will work within our Functional Service Provider (FSP) division, collaborating with clients and internal teams on study design, protocol writing, and final analyses.

Applicants should have advanced biostatistics training, strong SAS, CDISC experience, and ICH-GCP knowledge, with the ability to manage multiple trials and interact with

Qualificações

• Advanced degree in biostatistics or related field.
• 6+ years biostatistics experience in clinical research.
• Experience with ICH-GCP guidelines and clinical trial regulations.
• CDISC standards knowledge and implementation experience.
• Experience interacting with regulatory authorities (FDA/EMA).
• Experience in CRO/vendor management is a plus.

Responsabilidades

• Contribute to statistical tasks across the full clinical trial process.
• Design studies and develop protocols with rigorous statistical methods.
• Lead statistical analyses and reporting for multiple trials.
• Prepare analysis plans and review statistical outputs with stakeholders.

Conhecimentos

Biostatistics

SAS programming

ICH-GCP

CDISC

Regulatory interaction

Formação académica

Advanced degree in Statistics/Biostatistics

Ferramentas

R

EAST

WinBUGS

Descrição da oferta de emprego

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

About the Opportunity

What if your work could help to advance immunology insights through innovation—while keeping patients at the center of every decision? In this embedded PPD role as Clinical Trial Lead at a young, dynamic, global biotech company, you’ll work as respected member in an entrepreneurial organization where people take shared ownership, collaborate across connected teams and keep learning and developing as they work toward new possibilities for patients living with autoimmune disease. Be curious, committed, and contribute to groundbreaking ideas, build strong partnerships and grow through meaningful work that contributes to a bigger purpose.

DESCRIPTION:

Join our Clinical Research team as a Principal Scientist in Biostatistics, where you'll contribute to advancing life-changing therapies through statistical excellence. As part of our Functional Service Provider (FSP) division, you'll work closely with clients while utilizing the benefits and resources of an established leader in clinical research. You'll be responsible for implementing diverse statistical tasks throughout the full clinical trial process, from study design and protocol writing to final analysis and reporting. This position offers the opportunity to impact health outcomes while working with advanced clinical development programs.

REQUIREMENTS:

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in biostatistical experience in clinical research, with emphasis on Phase I-III trials
• Preferred Fields of Study: Statistics, Biostatistics, or related quantitative field
• Expert-level proficiency in SAS programming and statistical methodology
• Strong knowledge of ICH-GCP guidelines and clinical trial regulations
• Demonstrated experience in statistical analysis plan development and review
• Ability to manage multiple clinical trials simultaneously
• Advanced knowledge of CDISC standards and their implementation
• Experience with statistical software packages such as R, EAST, or WinBUGS
• Strong analytical and problem-solving skills
• Excellence in written and verbal communication
• Ability to interact effectively with regulatory authorities (FDA, EMA)
• Experience in CRO environment and vendor management preferred
• Knowledge of auto-immune and/or oncology therapeutic areas beneficial
• Demonstrated ability to work collaboratively in teams
• Ability to meet deadlines and manage competing priorities
• Strong attention to detail and quality focus

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.